Catalent Pharma Solutions, a provider of drug-delivery technologies and development solutions for drugs, biologics and consumer health products, has formed a collaboration with Valerion Therapeutics, LLC, an emerging science-driven company, focused on the development of biotherapeutics for orphan genetic diseases, to develop Valerion's two lead product candidates. The collaboration will focus on the delivery of muscle-protein fusions and treatment of multiple indications in the fields of muscular dystrophies, glycogen storage diseases, myopathies and enzyme-deficiency disorders.

Under the agreement, Catalent will provide all cell-line engineering, process development, and cGMP biomanufacturing activities associated with the two lead products, which use a novel antibody-based targeting system, capable of enhanced intracellular delivery of functional proteins, oligonucleotides, and small molecules. The project will use Catalent's proprietary GPEx technology for producing mammalian cell lines. Should initial studies prove successful, the therapies will be produced at Catalent's Madison, Wisconsin site, a purpose-built facility for mammalian cell culture development and cGMP manufacturing using up to 1,000-L single-use bioreactors.

Source: Catalent Pharma Solutions